PneumothoraxDARTTNCT00575198
Drainage Amount for Removal of Thoracostomy Tube
A study testing No drainage threshold and Drainage <2 mL/kg in people with Pneumothorax and Pleural Effusion, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to determine whether chest tubes can be safely removed without considering how much fluid is draining through the tube. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Pneumothorax, Pleural Effusion
- What is being tested?
- No drainage threshold and Drainage <2 mL/kg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Thoracostomy tube in place for <72 hours
- Age at least 14 years
- Hospitalized for traumatic injury or elective operation
Who cannot join
- Thoracostomy tube already removed from the pleural cavity of interest
- Mediastinal tubes
- Death expected within 48 hours
- Prisoner status
- Severe congestive heart failure
- End-stage liver disease
Show all 13Show fewer
- End-stage renal disease
- History of or suspected empyema involving the pleural cavity of interest
- History of or anticipated need for pleurodesis of the pleural cavity of interest
- Malignant pleural effusion
- Pregnancy
- Previous participation in this study
- Thoracostomy tube drainage already <2 mL/kg
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis, Medical Center
Sacramento, California, 95817
About this study
Official title: Non-inferiority Randomized Trial Evaluating Removal of Thoracostomy Tubes Independent of the Drainage Amount Versus Removal When the Drainage Amount Is Low
The purpose of this study is to determine whether chest tubes can be safely removed without considering how much fluid is draining through the tube.
Read the detailed description
Thoracostomy tubes are routinely used to drain the pleural space of fluid and gas to optimize pulmonary mechanics. Clinicians frequently postpone removal of thoracostomy tubes if the drainage from the tube exceeds a specific volume threshold for the prior 24 hours. However, there is substantial variability in the drainage volume threshold that different clinicians use, and no threshold has been established as clearly superior to any other. Removing tubes independently of the drainage volume may result in a greater risk of pleural effusion or pneumothorax requiring an invasive drainage procedure. However, removing tubes independently of the drainage volume might also expedite recovery by allowing earlier removal of the tube, thus diminishing pain and increasing patient mobility.
Thoracostomy tube management practices, including the drainage volume threshold used, may be dissimilar for different types of disease processes, so this study will be restricted to patients who required a thoracostomy tube for treatment of traumatic injury.
- Conditions
- Pneumothorax, Pleural Effusion
- Being tested
- No drainage threshold, Drainage <2 mL/kg
- Keywords
- Chest tubes, Trauma
- Medical subject headings
- Pneumothorax, Pleural Effusion, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No drainage thresholdOther
Removal of the thoracostomy tube independently of the amount of fluid that drained from the tube in the prior 24 hours
Drainage <2 mL/kgOther
Also called Standard thoracostomy tube management
Removal of the thoracostomy tube only if the drainage from the tube in the prior 24 hours is less than 2 mL/kg of the patient's ideal body weight
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | No drainage threshold Receives: Other: No drainage threshold |
| 2 | Active comparator | Drainage <2 mL/kg Receives: Other: Drainage <2 mL/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive drainage procedure
Measured: Within 60 days
Secondary outcomes (3)
Time to thoracostomy tube removal
Measured: Within 60 days
Pulmonary symptoms
Measured: 60 days
Mortality
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumothoraxStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Garth H Utter, MD MSc, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00575198
- Sponsor's protocol ID
- 200715709
- Acronym
- DARTT
- Status last verified
- Jun 2017
- First submitted
- 14 Dec 2007
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority Randomized Trial Evaluating Removal of Thoracostomy Tubes Independent of the Drainage Amount Versus Removal When the Drainage Amount Is Low
- ClinicalTrials.gov ID
- NCT00575198
- Acronym / sponsor ID
- DARTT / 200715709
- Conditions
- Pneumothorax, Pleural Effusion
- Keywords
- Chest tubes, Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 18 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether chest tubes can be safely removed without considering how much fluid is draining through the tube.
Detailed description
Thoracostomy tubes are routinely used to drain the pleural space of fluid and gas to optimize pulmonary mechanics. Clinicians frequently postpone removal of thoracostomy tubes if the drainage from the tube exceeds a specific volume threshold for the prior 24 hours. However, there is substantial variability in the drainage volume threshold that different clinicians use, and no threshold has been established as clearly superior to any other. Removing tubes independently of the drainage volume may result in a greater risk of pleural effusion or pneumothorax requiring an invasive drainage procedure. However, removing tubes independently of the drainage volume might also expedite recovery by allowing earlier removal of the tube, thus diminishing pain and increasing patient mobility.
Thoracostomy tube management practices, including the drainage volume threshold used, may be dissimilar for different types of disease processes, so this study will be restricted to patients who required a thoracostomy tube for treatment of traumatic injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: No drainage thresholdNo drainage threshold |
| 2 | Active comparator | Other: Drainage <2 mL/kgDrainage <2 mL/kg |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Thoracostomy tube in place for <72 hours
- Age at least 14 years
- Hospitalized for traumatic injury or elective operation
Key exclusion criteria (13 listed)
- Thoracostomy tube already removed from the pleural cavity of interest
- Mediastinal tubes
- Death expected within 48 hours
- Prisoner status
- Severe congestive heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No drainage thresholdRemoval of the thoracostomy tube independently of the amount of fluid that drained from the tube in the prior 24 hours | Other | 1 |
| Drainage <2 mL/kgAlso: Standard thoracostomy tube managementRemoval of the thoracostomy tube only if the drainage from the tube in the prior 24 hours is less than 2 mL/kg of the patient's ideal body weight | Other | 2 |
Primary outcome
Invasive drainage procedure
Time frame: Within 60 days
3 secondary outcomes
Time to thoracostomy tube removal
Time frame: Within 60 days
Pulmonary symptoms
Time frame: 60 days
Mortality
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Garth H Utter, MD MSc principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No drainage threshold and Drainage <2 mL/kg in people with Pneumothorax and Pleural Effusion, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive drainage procedure (time frame: Within 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2017.